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临床试验/NCT06387667
NCT06387667招募中不适用

Unveiling the Fungal Frontier: Characterizing Diversity and Antifungal Resistance in Immunocompromised ICU Patients With Respiratory Tract Infections

New Valley University1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2025年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
250
试验地点
1
主要终点
Number of fungal species causing pneumonia in immunocompromised ICU patients

研究概览

简要总结

Immunocompromised individuals face a heightened risk of life-threatening fungal infections, which arise from a multitude of environmental and commensal fungi. Surveillance data from ICUs worldwide identifies Candida spp. as the dominant foe, responsible for 80% of such infections, earning it the dubious distinction of being the third most prevalent pathogen. While C. albicans holds the dubious crown as the most common Candida offender, recent years have witnessed a concerning trend toward non-Albicans candida, raising concerns about potential antifungal resistance.

详细描述

For critically ill patients in the ICU, the threat of invasive fungal infections is a hidden danger, particularly in the presence of any of the following opportunistic factors:

(A) Pre-existing lung disease: Idiopathic pulmonary fibrosis (IPF) , Chronic obstructive pulmonary disease (COPD), or Sarcoidosis.

(B) Patient comorbidities:

  1. Immunosuppression: Neutropenia, Corticosteroid therapy, Immunosuppressive medication for inflammatory or autoimmune diseases; T-cell suppressants: Antithymocyte globulin (ATG), Calcineurin inhibitors (e.g., tacrolimus, cyclosporine) or B-cell suppressants: Rituximab, Severe sepsis (immune paralysis): Inherited severe immunodeficiency: Chronic granulomatous disease (CGD), Wiskott-Aldrich syndrome (WAS), and Common variable immunodeficiency (CVID) or Acquired immunodeficiency due to HIV/AIDS.
  2. Underlying medical conditions: Liver failure, Diabetes mellitus, or cardiovascular disease.
  3. Viral Pneumonia: Influenza-associated pulmonary aspergillosis (IAPA) and Coronavirus disease 2019 (COVID-19)
  4. Hematological and solid malignancies.
  5. Hematopoietic stem cell transplantation (HSCT).
  6. Prior fungal exposure: Aspergillus colonization before or during ICU admission .

(C) Environmental factors: Construction work, Geo-climatic factors, Tobacco or cannabis use, Air, food, or spice contamination, Gardening activity or occupation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients (aged >18 years old) admitted to the Assiut University Hospital's intensive care units with pneumonia and hospitalized patients who developed hospital-acquired or ventilator-associated pneumonia who don't respond to antibiotics for 48 hours or with a CT finding suspected for fungal pneumonia.
  • Patients included must have at least one of the following conditions as a contributor to immunocompromise:
  • Pre-existing lung disease: IPF, COPD, or sarcoidosis.
  • Immunosuppression: Neutropenia, on corticosteroids, or immunosuppressive drugs, inherited or acquired immunodeficiency.
  • Underlying comorbidities: (Diabetes Mellitus,Chronic kidney disease, Liver cirrhosis)
  • Malignancy (Hematological or solid)

排除标准

  • Patients refused to contribute to the study.
  • Unsatisfactory sample.

研究组 & 干预措施

Immunocompromised ICU patients

Experimental

Immunocompromised ICU Patients with Respiratory tract infections

干预措施: Complete blood count (Diagnostic Test)

Immunocompromised ICU patients

Experimental

Immunocompromised ICU Patients with Respiratory tract infections

干预措施: C-reactive protein, urea, creatinine, Random blood glucose (RBG), aspartate aminotransferase (AST), alanine aminotransferase (ALT) (Diagnostic Test)

Immunocompromised ICU patients

Experimental

Immunocompromised ICU Patients with Respiratory tract infections

干预措施: CT chest (Radiation)

Immunocompromised ICU patients

Experimental

Immunocompromised ICU Patients with Respiratory tract infections

干预措施: Microscopic examination (Diagnostic Test)

Immunocompromised ICU patients

Experimental

Immunocompromised ICU Patients with Respiratory tract infections

干预措施: culture and sensitivity (Diagnostic Test)

结局指标

主要结局

Number of fungal species causing pneumonia in immunocompromised ICU patients

时间窗: baseline

次要结局

  • Determine the antifungal susceptibility profiles of the identified fungal isolates.(baseline)
  • Number of associated specific patient factors with the type or antifungal resistance of fungal infections(baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa Nady Hussein

Lecturer of Internal Medicine

New Valley University

研究点 (1)

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